Seroma Prevention After Body Contouring Procedures

Not Applicable

• Conditions: Abdominoplasty; Complication of Surgical Procedure; Seroma
• Interventions: Procedure: Variable drain usage

• Registration Number: NCT03190876
• Lead Sponsor: University of Regensburg

Brief Summary

With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study

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Exclusion Criteria

• Minors or patients with a designated health care proxy, revision surgeries, morbid obesity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No drain	Variable drain usage	Conventional body contouring procedure, no application of drains
Passive drain	Variable drain usage	Conventional body contouring procedure, application of drains without suction (passive drainage), drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7

Primary Outcome Measures

Name	Time	Method
Rate of seroma formation	Weekly follow-up until postoperative week 6.	As primary outcome this study measures the rate of seroma requiring evacuation via puncture aspiration (fluid retention \> 20 cc) in each group.

Trial Locations

Locations (1)

Department of Plastic Surgery, University Hospital of Regensburg; 🇩🇪 Regensburg, Bayern, Germany